ACETAMINOPHEN AND IBUPROFEN- acetaminophen and ibuprofen tablet 
Granules India Limited

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Acetaminophen and Ibuprofen

PRINCIPAL DISPLAY PANEL

62207-588-32

ACETAMINOPHEN AND IBUPROFEN 
acetaminophen and ibuprofen tablet
Product Information
Product TypeBULK INGREDIENTItem Code (Source)NDC:62207-588
Route of AdministrationNOT APPLICABLE
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN125 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE K30 (UNII: U725QWY32X)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE (UNII: 2S7830E561)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Coloryellow (Light yellow to yellow colored) Scoreno score
ShapeCAPSULE (capsule shaped, biconvex) Size14mm
FlavorImprint Code G;131
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-588-3210000 in 1 DRUM08/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only08/30/2023
Labeler - Granules India Limited (915000087)
Establishment
NameAddressID/FEIBusiness Operations
Granules India Limited918609236analysis(62207-588) , manufacture(62207-588)

Revised: 8/2023
Document Id: 042216a1-827a-7d8f-e063-6294a90a0c7e
Set id: 04220712-9ced-17ff-e063-6294a90ac4d5
Version: 1
Effective Time: 20230830
 
Granules India Limited